Recently, the National Medical Products Administration approved the registration application for the chromosomal karyotype image-assisted diagnostic software from Hangzhou Diagens Biotechnology Co., Ltd.

The product consists of a software installation CD andU-Shield Composition: The software function modules include a user login interface module, a main interface module, and an analysis interface module. This product is used for the analysis of G-banded chromosome karyotype images from peripheral blood and amniotic fluid samples, providing technical professionals with auxiliary diagnostic support for karyotype analysis. The suspected chromosomal abnormalities it identifies cannot be used as the sole basis for clinical diagnostic decisions.

The product can automatically complete chromosome segmentation, counting, recognition, arrangement, and abnormality auxiliary prompts by reading metaphase chromosome images, combining traditional image processing techniques with artificial intelligence algorithms. It improves detection efficiency and provides patients with more efficient auxiliary detection services.

The drug supervision and administration department will strengthen the post-marketing supervision of the above-mentioned products to protect the safety of patients using medical devices.